Catalog Number 8884719009 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/14/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time since the sample is not available it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the device sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend on similar complaints.
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Event Description
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The customer alleges that the device is leaking during treatment.No patient injury reported.
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Manufacturer Narrative
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(b)(4).The customer did not return the actual complaint sample, however, they did return three samples of the same lot number.A visual exam was performed on the units and no defects were observed.A functional test was performed on the returned units using a vacuum line.Each unit was connected to a vacuum line and immediately, both the white inner piston and the yellow inner flow cap moved.The units were confirmed to function properly.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned devices.
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Event Description
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The customer alleges that the device is leaking during treatment.No patient injury reported.
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Search Alerts/Recalls
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